Pregnancy Clinical Trial
Official title:
"Fetal Aneuploidy Screening (21, 18 and 13) by Analysis of Circulating Fetal DNA in a Population of Pregnant Patients With Autoimmune Diseases"
In the plasma of any pregnant patient circulates DNA (also called circulating free DNA). The
vast majority of this circulating free DNA is of maternal origin and about 10% is of fetal
origin (fetal circulating free DNA). This percentage of fetal circulating free DNA
(corresponding to the fetal fraction) increases with gestation.
The pathophysiological hypothesis of this research is that there is a change in the fetal
fraction (FF) of fetal circulating free DNA in patients with autoimmune disease (AID). The
underlying mechanism would be a massive release of maternal cfDNA responsible for a dilution
of fetal cfDNA. This dilution of fetal cfDNA would result in a decrease in the estimate of
the foetal fraction of circulating free DNA. However, when the foetal fraction of circulating
free DNA is insufficient (4% most often), screening for Trisomy 21 (T21) by fetal circulating
free DNA becomes uninterpretable (NC for "non-contributory" result), and cannot be used to
assess the risk of T21. In this case, the dose of fetal circulating free DNA can be performed
again after 15 days, as the amount of fetal circulating free DNA increases with gestation. In
a small number of cases the result will remain NC.
As tests using DNA are becoming more widespread, it is important to prospectively evaluate
the results of these tests in the population of patients with AID, which represents about 3
to 5% of pregnant women.
Circulating fetal DNA (cfDNA) in maternal blood is now routinely used for prenatal screening
for Down syndrome 21 (T21). In about 1% of cases, the test result is not contributory (NC).
The investigator's team recently found, in a retrospective study, an association between the
existence of an autoimmune disease (AID) and a high risk of NC. However, this was only a
subgroup analysis, requiring confirmation by a dedicated study. Tests using deoxyribonucleic
Care (dNCare) are becoming more widespread, so it is important to prospectively evaluate the
results of these tests in the population of patients with AID, which represents about 3 to 5%
of pregnant women.
The main objective of this study is to compare the rate of NC in a population of patients
with DIA to that of a population of patients without MAI when screened for T21 by the cfDNA
study in the first trimester of pregnancy.
The secondary objectives are :
- To assess the performance of fetal cfDNA for T21 screening in the population of PATIENTS
with AID and to compare them with performance in the non-auto immune disease population.
- To assess the performance of the combined first trimester screening for T21 screening
and compare it with those of fetal cfDNA in the population of patients with AID.
- In patients with an NC result, analysis of the distribution of fetal fractions according
to the presence and severity of maternal autoimmune pathologies. The distribution will
be compared to that of the control population.
- To assess the association between fetal fraction and the occurrence of vascular
complications of pregnancy in both groups with and without auto immune disease.
AFFEPI is a prospective multicenter, interventional, exposed/non-exposed cohort study
There are two group :
Exposed group: Any patient with a auto immune disease followed at one of the 14 centres who
wants to be screened for T21.
Unexposed group: Patients who do not carry an auto immune disease identified at the interview
(no history of auto immune disease; no symptoms suggestive of a auto immune disease).
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